pharmacovigilance: Risk minimisation activities

Quick reference guide

This guide describes what pharmacovigilance is, highlights the importance of risk management plans, explains the difference between routine and additional risk minimisation activities, and discusses the way in which risk minimisation information can be accessed.

This guide provides an overview of pharmacovigilance risk management and risk minimisation activities, highlighting the roles that healthcare professionals (HCPs), including pharmacists, play in supporting the safe and effective use of medicines. 

What is pharmacovigilance? 

Pharmacovigilance involves monitoring the safety of medicines and taking action to reduce any identified risks, thereby supporting the safe and effective use of medicines by patients; in general terms it includes errors in the ‘drug use process’ and effects arising directly from the use of medicines

Why is pharmacovigilance important? 

Once a medicine has been authorised and is on the market, pharmacovigilance activities carried out by pharmaceutical companies and regulatory authorities continue to monitor the safety profile of the medicine and take action to minimise the risks of any changes in that safety profile. 

What activities comprise pharmacovigilance? 

Pharmacovigilance activities include: 

  • The collection and assessment of safety related information to determine the benefit/risk impact 
  • Implementing risk management strategies to minimise risks associated with medicines use • Communication of any risk to the public and HCPs 
  • Assessing the effectiveness of pharmacovigilance activities 

Who contributes to pharmacovigilance?

  • For pharmacovigilance to be effective, it requires the input of a wide range of stakeholders including: 
  • HCPs, including pharmacists 
  • The public including patients or their carers 
  • Regulatory authorities and pharmaceutical industry associations 
  • Pharmaceutical companies 

What is a risk management plan? 

A risk management plan (RMP) is a set of activities designed to identify and prevent or minimise risks related to a medicine. A RMP is written by a pharmaceutical company and is continually updated throughout the lifecycle of a medicine as the understanding of a risk increases and the missing information decreases. 

What is a risk minimisation strategy? 

A RMP must include a risk minimisation strategy which documents the risk minimisation measures (routine or additional). Risk minimisation can either reduce the severity of the risk when it occurs or reduce its frequency. 

What are routine risk minimisation activities? 

For most medicines routine risk minimisation is considered sufficient and includes tools such as:

  • Summary of Product Characteristics 
  • Patient Information Leaflet 
  • Labelling and packaging of the medicine 
  • Legal status of the medicine 

Why are additional risk minimisation activities required? 

Additional risk minimisation activities apply to some new medicines, or for older products where a safety issue has been identified, to improve the benefit/risk profile. 

Examples of additional risk minimisation activities include: 

  • Educational programmes for HCPs, patients and care givers 
  • Patient screening or monitoring 
  • Patient alert cards (e.g. anticoagulants) 

Other more restrictive types of activities would include pregnancy prevention schemes, e.g. thalidomide, and controlled access programmes, e.g. clozapine.

How is information communicated? 

For some medicines, a communication plan is developed to educate HCPs and patients. Such a plan typically involves the distribution of educational materials or tools containing key safety messages to HCPs. Such materials are non-promotional. Pharmacists may be involved in the dissemination of educational materials or key safety messages/alert cards to patients or care givers, or in educating other HCPs about the safety requirements for medicines.

How can these educational materials be accessed? 

For some medicines, risk minimisation materials can be downloaded via the electronic Medicines Compendium (eMC). Other materials, including alert cards, are available in the product packs or directly from the Marketing Authorisation Holder (MAH). 

Are risk minimisation activities assessed? 

MAHs are legally required to evaluate their risk minimisation activities to ensure their effectiveness. This evaluation may take the form of a survey with patients and HCPs. Consequently pharmacists may be approached to participate in these studies, to recruit patients, or facilitate audits of pharmacy and patient records.

Where to go for further information

RPS RESOURCES

external resources

Details
   

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Produced in conjunction with the ABPI Pharmacovigilance Expert Network.